Lunchtime pandemic reading.
Standard disclaimer: this is a roundup of informative pieces I've read that interest me on the severity of the crisis and how to manage it. I am not a qualified medical expert in ANY sense; at best I am reasonably well-read laity. ALWAYS prioritize advice from qualified healthcare experts over some person on Facebook.
This is also available as an email newsletter at https://lunchtimepandemic.substack.com if you prefer the update in your inbox.
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Are the vaccines safe? Some consternation in Europe, explained. "New @PEI_Germany report provides much needed clarity to the #AstraZeneca "pause" in Germany. Not yet available in English. I will try to summarize. /thread
As of Monday (March 15th), 2021, 7 cases of specific form of severe cerebral venous thrombosis associated with platelet deficiency (thrombocytopenia) were identified. The individuals were 20-50 years old and 3 of them subsequently died. /2
6 of the cases were women who had a particular form of cerebral venous thrombosis, namely cerebral venous sinus thrombosis. (hopkinsmedicine.org/health/conditi…) The 7th case was medically very similar (cerebral hemorrhage + platelet deficiency + thrombosis)
All cases occurred 4 to 16 days after vaccination with AstraZeneca COVID-19 vaccine. This pattern "flagged" in the surveillance data. This is what we hope good surveillance does- detect potential concerning events & investigate further. /4
The PEI writes that this number of cases following #AstraZeneca vaccination was found to be statistically significantly higher than the number of cerebral venous thromboses that normally occur in the general population. /5
The PEI ran an "observed-versus-expected analysis", comparing the # of such cases expected *without* vaccination in a 14-day period with the # of cases reported in those vaccinated with #AstraZeneca (1.6 million) in Germany. About 1 case would be expected, 7 were observed. /6
The younger to middle-aged population in which these severe cerebral venous thromboses+platelet deficiency was observed is not the group at highest risk for a severe/fatal COVID-19. (Sidenote: this is why so many of us wanted information on age group yesterday) /7
The PEI states that they consulted other experts in thrombosis, hematology, and an adenovirus specialist about this issue & all unanimously agreed that a pattern could be recognized here & a connection between the reported cases and the AZ vaccination "was not implausible". /8
They go on to explain that these aforementioned points led to yesterday's decision by the @PEI_Germany to recommend suspension of the #AstraZeneca COVID-19 vaccine as a precautionary measure until further assessment can be completed. /9
The German Federal Ministry of Health (BMG) followed this recommendation. The Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA) will also review this information this week. /10
Now we await the #EMA comments & decision on whether and how these observations (together with other European surveillance data) affect the risk-benefit profile of the AstraZeneca COVID-19 vaccine and the EU approval of the vaccine. /11
At this point, it remains unclear whether there is a causal relationship between the #AstraZeneca vaccine and these cases of cerebral thrombosis. /12
The main report is followed by a series of Q&A. I will highlight the @PEI_Germany answer to Q#6: "What can I do if I have received vaccination with AstraZeneca COVID-19 vaccine?" since many are likely faced with this question today. /13
The report emphasizes how rare these cerebral venous thrombosis events were (7 out of 1.6 million vaccinations, according to current knowledge). They point out that these individuals continued to feel unwell and experienced increasing headaches 4-16 days after vaccination. /14
Thus, the @PEI_Germany advises that people who have received the AstraZeneca COVID-19 vaccine and feel *increasingly* unwell more than four days after vaccination - with severe and persistent headaches or pinpoint bleeding on the skin seek professional medical advice. /15
Q7 asks "What changed since Friday?" The report explains that on Friday, the number of incident cerebral venous thrombosis events that occurred within the vaccinated population was still within a range that would be expected in the general (unvaccinated) population. /16
They describe the process of observed vs. expected analysis in pharmacovigilance (drug safety) and go on to say that on Friday, the threshold for the "red flag" had not yet been reached. /17
If the frequency of an event (like the cerebral venous thrombosis, in this case) is near the expected frequency, this speaks for a *random* occurrence in temporal connection with the vaccination. /18
On Monday, the 2 additional cases of cerebral venous thrombosis were reported following #AstraZeneca vaccination. These additional 2 cases put the number of observed cases "well above the expected number" & ultimately led to the decision to suspend, they write. /19&end
Now, we eagerly await more info & the #EMA recommendation. Of course, serious events in close temporal relation to vaccine should be taken seriously & weighed carefully against the strong, demonstrated benefits of the vaccine.
Since #AstraZeneca was the primary vaccine strategy in Germany and much of Europe, every day we wait is a frustrating one. I do appreciate the transparency of this report. Wish these numbers had been released yesterday though!"
Source:
Commentary: The Oxford/AstraZeneca vaccine is the one in question here - no issues with other vaccines and cerebral venous thrombosis have occurred. We have 7 cases of an issue out of 1.6 million vaccinations in the EU for just one vaccine. The guidance issued by the EU to stop using that vaccine in the EU seems... on statistically shaky ground, particularly since other vaccines in the EU are in shorter supply. Nonetheless, the caution is understandable.
Short version: if you were vaccinated with the Oxford/AZ vaccine recently (UK and EU friends), and you feel increasingly unwell, consult a doctor soon, especially if you have known issues with platelet counts. If you were vaccinated with any other vaccine, this particular issue is not a problem.
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A new strain evades detection. "French authorities are warning of a new coronavirus variant in the northwestern region of Brittany that escapes detection by standard PCR tests.
While harder to detect, the "initial analyses of this new variant doesn't suggest either increased severity or increased transmissibility," the health ministry said in statement late Monday.
The World Health Organization has placed this new strain in its category of "variant under investigation" due to its bypassing PCR tests. This category includes most of the thousands of variants that occur naturally — of which only a small proportion will pose public health problems — as opposed to the "variant of concern" category, which includes strains found in Brazil, the U.K. and South Africa.
An in-depth investigation is underway in Brittany, after eight cases were identified as carriers of the variant from sequencing in a cluster of 79 cases in the town of Lannion.
The announcement came as France battles a resurgence in coronavirus cases, with President Emmanuel Macron warning that new lockdown measures could come in coming days."
Source: https://www.politico.eu/article/new-french-coronavirus-variant-might-bypass-pcr-tests/
Source: https://solidarites-sante.gouv.fr/IMG/pdf/cp_nouveau_variant_15-03-2021.pdf
Commentary: What we're witnessing is evolution - as the virus evolves, natural selection is taking place. Evading immune responses, such as what the B.1.351 strain does, is one form of escaping selection pressure. Evading the test entirely, which is what this new strain does, is another form. These changes provide the virus with survival advantage, and is why we need to vaccinate fast, fast, fast - to cut down the number of hosts that can not only carry the virus, but give it further mutation opportunities. So far, only the B.1.351 strain has shown greater antibody resistance - other strains simply spread faster. That won't last for long.
Every vaccination shuts down another node in the network, another chance for the virus to spread and mutate. Cheer on every vaccination, because it not only benefits the recipient, but everyone else too.
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Another test cheater. "Virus variants have been scientists' main struggle while vaccine efforts started to pick up steam around the world against the global COVID-19 pandemic, and now a new strain in Finland may have mutated in a way that enables it to escape detection in polymerase chain reaction (PCR) tests, according to experts.
Helsinki-based Vita Laboratories said the variant Fin-796H was different from strains previously found in South Africa and the U.K. and that the new mutated coronavirus may not show up in PCR tests, Finland's national public broadcaster YLE reported.
"The variant was discovered in a patient last week, so details about the infectivity and potential resistance of this strain to vaccines are not yet known," Taru Meri, a researcher at Vita Laboratories, told Yleisradio Oy (YLE), Finland's national public broadcaster."
Source: https://www.dailysabah.com/life/health/new-covid-19-mutation-in-finland-may-escape-pcr-tests
Commentary: Test cheating virus strains mean that just because someone tests clear, doesn't mean they're actually not infected. They may be infected with strains that cheat on the test. The countermeasure for this is to keep observing protections at all times outside your home. Wear the best mask available to you. Double mask if it's less than an N95/P95/KN95. Keep out of gatherings and indoor spaces that aren't your home. Get vaccinated as soon as you're eligible.
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Moderna begins infant-12 year old study. "Moderna Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the first participants have been dosed in the Phase 2/3 study, called the KidCOVE study, of mRNA-1273, the Company’s vaccine candidate against COVID-19, in children ages 6 months to less than 12 years. The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
“We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy children in the U.S. and Canada and we thank NIAID and BARDA for their collaboration,” said Stéphane Bancel, Chief Executive Officer of Moderna. “It is humbling to know that 53 million doses have been administered to people in the U.S. We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above and this pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population.”"
Source: https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-first-participants-dosed-phase-23-study-0
Commentary: Moderna is looking for people with kids to enroll them in the trial. Remember that this isn't a new product - they're testing the proven adult vaccine in kids to make sure there aren't any new surprises in younger immune systems. And no, your kid cannot get COVID-19 from the vaccine - and neither can you.
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A reminder of the simple daily habits we should all be taking.
1. Always wear the best mask available to you when out of your home and you'll be around other people. Respirators are back in stock at online retailers, too. Wear an N95/FFP2/KN95 that's NIOSH-approved or better mask if you can obtain it. If you can't get an N95 mask, wear a surgical mask with a cloth mask over it.
2. Get vaccinated as soon as you're able to.
3. Wash/sanitize your hands every time you are in or out of your home for any reason.
4. Stay home as much as possible. Minimize your contact with others and maintain physical distance of at LEAST 6 feet / 2 meters, preferably more. Avoid indoor places as much as you can; indoor spaces spread the disease through aerosols and distance is less effective at mitigating your risks.
5. Get your personal finances in order now. Cut all unnecessary costs.
6. Replenish your supplies as you use them. Avoid reducing your stores to pre-pandemic levels in case an outbreak causes unexpected supply chain disruptions.
7. Ventilate your home as frequently as weather and circumstances permit, except when you share close airspaces with other residences (like a window less than a meter away from a neighboring window).
8. Masks must fit properly to work. Here's how to properly fit a mask:
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Common misinformation debunked!
There is no mercury or other heavy metals in the Pfizer mRNA vaccine. https://www.technologyreview.com/2020/12/09/1013538/what-are-the-ingredients-of-pfizers-covid-19-vaccine/
There is no genomic evidence at all that COVID-19 arrived before 2020 in the United States and therefore no hidden herd immunity:
Source:
There is no evidence SARS-CoV-2 was engineered, nor that it escaped a lab somewhere.
Source: https://www.washingtonpost.com/world/2020/01/29/experts-debunk-fringe-theory-linking-chinas-coronavirus-weapons-research/
Source: https://www.nature.com/articles/s41591-020-0820-9
Source: https://www.nationalgeographic.com/science/2020/05/anthony-fauci-no-scientific-evidence-the-coronavirus-was-made-in-a-chinese-lab-cvd/
There is no evidence a flu shot increases your COVID-19 risk.
Source: https://www.factcheck.org/2020/04/no-evidence-that-flu-shot-increases-risk-of-covid-19/
Source: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa626/5842161
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A common request I'm asked is who I follow. Here's a public Twitter list of many of the sources I read.
https://twitter.com/i/lists/1260956929205112834
This list is biased by design. It is limited to authors who predominantly post in the English language. It is heavily biased towards individual researchers and away from institutions. It is biased towards those who publish or share research, data, papers, etc. I have made an attempt to follow researchers from different countries, and also to make the list reasonably gender-balanced, because multiple, diverse perspectives on research data are essential.
This is also available as an email newsletter at https://lunchtimepandemic.substack.com if you prefer the update in your inbox.